USPTO Patents Application 10597633

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Patent Cooperation Treaty (PCT)

International application number: PCT/IL05/000142

International filing date:

04 February 2005 (04.02.2005)

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Country/Office: US

Number: 60/566,078

Filing date: 29 April 2004 (29.04,2004)

Date of receipt at the International Bureau: 12 May 2005 (12.05.2005)

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2 0 APR 2005

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PROVISIONAL APPLICATION FOR PATENT COVER SHEET

TWs is a request for filing a PROVISIONAL APPLICATION FOR PATENT under 37 CFR 1.53(c).

INVENTOR®

Given Nam© (first and middle Pf any])

Omer
Ernesto

Family Name or Surname

EINAV
KORENMAN

Residence
(Crty and either State or ForeignCountry)

Mochav Kfarlflonash, Israel
Raanana, Israel

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' TITLE OF THE INVENTION (280 characters max)

NEUROMUSCULAR STIMULATION

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Roy N. Envall, Jr.

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2001 Jefferson Davis Highway, Suits 207

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Docket Number | 414/04031

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NEUROMUSCULAR STIMULATION
RELATED APPLICATIONS
This application claims the benefit under § 119(e) of U.S. Provisional
Application No. 60/542,022, filed on February 5, 2004, by Omer Einav et ah, and
5 U.S. Provisional Application filed on even date, titled "Fine Motor Control
Rehabilitation", attorney docket number 414/04032, the disclosure of both
applications are incorporated herein by reference.

FIELD OF THE INVENTION
The field of the invention is devices for rehabilitation of patients with motor
10 control problems.

BACKGROUND OF THE INVENTION
Voluntary muscle movement is caused by electrical impulses which originate
in the somato-motor cortex of the brain. A neuron in the somato-motor cortex sends
electrical signals to a motor neuron in the spinal cord, which in turn sends electrical
IS signals which stimulate the contraction of muscle fibers, producing movement. All of
the muscle fibers which are stimulated by a given motor neuron are called a "motor
unit." Each muscle fiber exhibits an electrical potential across its cell membrane,
which changes when the muscle contracts.

In electromyography (EMG), the difference in potential on the surface of the
20 skin is measured between the center and the ends of a muscle, which gives a measure
of the number of contracting muscle fibers. EMG is regularly used to diagnose a
variety of medical conditions in patients, as well as in healthy subjects for research on
muscle function.

In stroke patients with damage to their somato-motor cortex, electrical signals
25 are not generated for one or more muscles or parts of muscles, or do not reach those

*

muscles, and normal contraction of those muscles is impossible. Often, residual EMG
signals, too weak or too spread out to cause the muscles to contract, are still
detectable.

Neuromuscular electrical stimulation (NMES) is used to produce contraction
30 of a muscle which cannot contract normally in a stroke patient. NMES may stop
spasticity in a muscle, and may prevent the muscle from atrophying. It is also known
to turn NMES of a single muscle on or off in response to residual EMG signals
detected from that muscle, thereby allowing the muscle to contract under the control
of the patient.

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SUMMARY OF THE INVENTION
An aspect of an embodiment of the invention concerns applying NMES to a
paretic arm, or any other part of the body with voluntary muscles, at an amplitude that
would be too low to produce motion by itself, but which, in combination with nerve

5 impulses arising in the patient's motor cortex, allow the arm or other body part to
move, or to move more effectively than without the NMES. It does this, for example,
by producing muscular feedback which helps to train the motor cortex to move that
body part. In some embodiments, the NMES need not be very strong, or very
precisely directed, in order to do tins. Whenever this application refers to arms, it

10 should be understood that any other body part, or combination of body parts, with
voluntary muscles may be used instead. Optionally, EMG signals from the same arm,
or from the corresponding muscles in the patient's other arm, or from the arm of
another person, are used to determine the pattern of the NMES*

Another aspect of an embodiment of the invention concerns the use of EMG

IS signals from one arm, optionally a healthy arm, undergoing voluntary motion, to
determine a pattern of NMES to be applied to another, paretic arm. Optionally EMG
signals from the paretic aim are also used, at least to determine the timing of the
NMES. Optionally, the healthy arm is the other arm of the patient, and the patient
tries to move both arms in synchrony, in a mirror symmetric pattern.

20 Optionally, for either of these embodiments of the invention, the EMG and

NMES involve a coordinated sequence of contractions of more than one muscle,
and/or a range of amplitudes for the NMES, rather than having the NMES either on or
off for a single muscle.

By providing feedback, through the kinesthetic sense, of a coordinated

25 sequence of muscle contractions, the patient's nervous system may be encouraged to
utilize alternative undamaged pathways for nerve impulses, or alternative locations in
the motor cortex, and the patient can learn to move his arm more effectively on his
own. This may be especially tHie if the NMES is coordinated with the weak nerve
impulses that the patient produces on his own, as measured by the EMG,

30 Optionally, a device, for example a robotic arm, which monitors and displays

the movement of the arm, is used for the paretic arm, and optionally also for the
healthy arm if one is used. Information about the movement of the arm can provide
further feedback to the patient, as well as feedback for controlling the NMES, and
feedback to a physical therapist who is monitoring the progress of the patient's

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rehabilitatioa A robotic aim or similar device can also mechanically move the paretic
arm, complementing the NMES by providing a different kind of kinesthetic feedback.
A robotic arm can also exert a force working against the muscle, providing a way to
strengthen the ann as well as to measure progress in strengthening the aim.
5 BRIEF DESCRIPTION OF THE DRAWINGS

Exemplary embodiments of the invention are described in the following
sections with reference to the drawings. The drawings are generally not to scale and
the same or similar reference numbers are used for the same or related features on
different drawings.

10 Fig. 1 is a schematic drawing of a healthy arm with EMG electrodes, an EMG

unit, a signal processing unit, an NMES unit, and a paretic arm with NMES and EMG
electrodes, according to an exemplary embodiment of the invention;

Fig. 2 shows plots of a raw EMG signal, rectified signal, smoothed rms signal,
according to an exemplary embodiment of the invention;
15 Fig. 3 is a schematic drawing of an ann attached to a robot arm, according to

an exemplary embodiment of the invention;

Fig. 4 is a schematic drawing of a paretic arm with NMES electrodes and
EMG electrodes, nerve signals from brain, and a signal processing unit, according to a
different exemplary embodiment of the invention than Fig. 1; and
20 Figs. 5A-5G are a time sequence of plots of EMG signals from flexor and

extensor signals, at different times during rehabilitation, according to an exemplary
embodiment of the invention.

DETAILED DESCRIPTION OP E XEMPLAR V EMBODIMENTS
Fig. 1 shows an apparatus for applying NMES to several muscles of a paretic
25 arm, guided by EMG signals from the conresponding muscles of a healthy arm.
Healthy aim 102, belonging either to the patient with the paretic arm or to someone
eJse, has EMG electrodes attached to the skin. The person whose arm it is moves the
arm voluntarily in a particular pattern, which generates a certain time-dependent
pattern of EMG voltages in the muscles. There are optionally four EMG channels, one
30 channel measuring EMG signals from each of four muscles: the biceps, the triceps,
the flexors, and the extensors. Each channel uses three electrodes, two recording
signals from near each end of the muscle, and one reference electrode in the middle.
Thus, electrodes 104 measure the biceps, electrodes 106 measure the triceps,
electrodes 108 measure the flexors, and electrodes 110 measure the extensors. When

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the aim is moved voluntarily, these electrodes transmit the EMG signals
corresponding to the pattern of muscle contractions producing that movement of the
arm, via cable bundles 112, 114, 116, and 118, to an EMG device 120. The EMG
device, or a separate controller, does preliminary processing of the EMG signals, for
5 example amplifying them, digitizingthem, and/or recording them.

The EMG signals are then transmitted, via a cable 122, to a controller 124,
which is, for example, a personal computer, or comprises special dedicated hardware.
The controller optionally further processes the EMG signals, for example filtering
them, rectifying them, smoothing them, changing the timing, or cutting and pasting
10 parts of a sequence in a different order. The signal processing is optionally done

#

automatically, or is partly or entirely under the control the physical therapist. Fig. 2
shows a plot of a filtered raw EMG signal 202 from one channel, a rectified signal

* •

204, and a smoothed rectified signal 206, in which the root mean square of the signal
is calculated in each of a sequence of time intervals, or example every 10
15 milliseconds. The smoothed rectified signal is a measure of the overall degree of
contraction of the muscle or section of the muscle measured by that channel, while

♦

eliminating high frequency noise associated with the changes in potential of
individual muscle fibers. Optionally, the smoothed rectified EMG signal is averaged
over many repetitions of the same pattern of movement Optionally, the EMG sensors
20 add up or average the EMG signals coming from several different sections of the
muscle, or this is done by the signal processing. Optionally, one or more of the
parameters of the signal processing are controlled by the therapist.

Controller 124 also controls NMES device 126, via cable 128. Optionally,
controller 124 commands NMES device to produce NMES signals in each of four

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25 channels. The signals in the four channels travel through cables 130, 132, 134, and
136, to electrodes 138, 140, 142, and 144, which respectively stimulate the biceps,
triceps, flexors, and extensors on (he patient's paretic arm 146. Optionally, the NMES
signals in each channel are given a time-dependent amplitude which will produce the
same movement in the paretic arm as was performed by the healthy arm. This is done,

30 for example, by making the signal strength in each NMES channel depend on the
processed signal amplitude from a corresponding one of the four EMG channels. For
example, the NMES signal is proportional to the processed EMG signal amplitude, or
is a fixed monotonic function of the processed EMG signal amplitude, for the
corresponding channel.

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Optionally, the NMES signal depends also on the EMG signal fiom one or
more other channels. For example, because the biceps and triceps work against each
other, the NMES signals controlling the biceps and triceps, optionally depend on a
linear combination of the EMG signal from the biceps and the EMG signal from the
5 triceps, with a negative coefficient for the EMG signal from the triceps. If the linear
combination is positive, only the biceps is stimulated, and if the linear combination is
negative, only the triceps is stimulated: A similar method is optionally used for the
flexors and extensors which also work against each other.

Optionally, the NMES signals are based not directly on the EMG signals from
10 the corresponding muscles, but are modified to produce motion that is reversed in
some way from the motion associated with the EMG signals. For example, if the
EMG signals come from a left arm and the NMES signals are applied to a right arm,
then optionally the NMES signals are changed to produce motion in the right arm that
is the same as the motion of the left aim, rather than a inirror image of it, as would
15 occur if the corresponding muscles in the two arms were to contract at the same time.
Alternatively or additionally, whether or not the two arms are a left arm and a right
arm, if the motion of me healthy arm is cyclical, then the NMES signals are changed
to produce motion in the paretic arm that is 180 degrees out of phase from the motion
of the healthy arm. Such a modification in the NMES signals might be particularly
20 useful to use for the left and right legs, for example, in a patient who needs to relearn
how to walk.

Optionally, there are also EMG electrodes 148, 150, 152, and 154, attached to
the paretic arm. These sensors send signals along cables 156, 158, 160 and 162,
respectively, to four additional channels of EMG device 120, which thus has a total of

25 eight channels. These additional EMG signals are processed by the EMG device and
by controller 124, similar to the processing of the EMG signals from healthy arm 1 02.
Optionally, the EMG signals from paretic arm 146 are also used by controller 124 in
controlling the NMES signals. The EMG signals in paretic arm 146 may arise because
the sensory-motor cortex of the patient is still capable of producing weak nerve

30 impulses in paretic arm 146, even if these nerve impulses are too weak to cause the
paretic arm to move. By timing the NMES signals to the corresponding EMG signals
in the paretic arm, the paretic arm can move in response to the attempts of the patient
to move it, providing kinesthetic feedback to the patient. Alternatively or additionally,

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EMG signals in paretic arm 146 may be induced by moving paretic arm 146
passively, for example by a robot arm as discussed below in describing Fig. 3.

Optionally, controller 124 also uses other information in controlling the
strength of the NMES signals. For example, the healthy aim has a sensor 164, for
example a strain sensor, which measures the degree of bending of the elbow, and a
sensor 166 which measures the degree of extension of the fingers, while the paretic
arm has similar sensors 168 and 170. The sensors feed into a unit 172 which processes
the sensor data to determine the bending of the aim and fingers, and this information
is conveyed, for example by cable 174, to controller 124. Optionally, unit 172 and
controller 124 are part of a single control unit. Optionally, sensors are used only with
one of the aims. Optionally there are other sensors which measure other aspects of the
ann and hand position, particularly if EMG and NMES is used with additional
muscles. A variety of other types of sensors are additionally or alternatively used for
measuring the aim or hand position, for example the arm is fitted to a robot arm which
has such sensors to measure its own state, as shown in Fig. 3 which will be described
below. Or, LEDs are attached to key points on the aim and hand and their location
tracked with a video camera, or magnetic field sensors are attached to key points on
the ann and hand, and an external magnetic field and/or field gradient imposed. Other
methods will be apparent to those skilled in the art of sensing the position and
20 orientation of body parts.

The position of the paretic arm can be used, for example, as negative feedback
to the NMES signals. During the course of rehabilitation, as the patient's own nerve
impulses become stronger and/or more effective, for example cfistinguishing better
between antagonistic pairs of muscles, the NMES signal can be reduced while
producing the same ann motion. This kind of feedback can also be used within a
given rehabilitation session. For example, if the patient is momentarily having trouble
continuing to move his arm, the NMES amplitude is momentarily increased, until the
patient is able to start moving his arm again. Optionally, in this case, the controller
distinguishes between the patient simply resting, and the patient trying unsuccessfully
to move his ann, for example by looking at EMG signal levels in the paretic arm.

The position of the healthy arm can be used, for example, to supplement the
EMG signals from the healthy arm, as a measure of the degree of contraction of the
muscles in the healthy arm. Alternatively or additionally, the data on position of both
arms can be used to monitor the progress of the rehabilitation of the patient.

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Fig. 3 shows an arm 302, which could be either the healthy arm or the paretic
arm in Fig. 1, attached to a robot arm 300. The upper arm is held by a holder 304, and
the lower aim is held by a holder 306. Upper arm holder 304 is attached to an
extendable rod 308, which is connected to a controllable ball joint 310, and similarly
lower arm holder 306 is attached to an extendable rod 312, which is connected to a
controllable ball joint 314. Ball joints 310 and 314 are connected to each other with a
rigid connector 316. The ball joints and extendable rods include both actuators and
sensors, for all their degrees of freedom, in this case two degrees of freedom for each
ball joint, and one degree of freedom for each extendable rod. The sensors can' sense
the degree of bending of the elbow of aim 302, and the actuators can apply force to
bend or unbend the elbow, and/or to resist bending or unbending of the elbow by the
patient. Optionally, the actuators and sensors have more or fewer degrees of freedom,
depending for example on which muscles are being rehabilitated, and optionally the
robot arm is attached to additional points on arm 302, for example to different points
15 on the wrist, hand, and fingers. Signals .from the sensors and to the actuators are
processed by a robot arm control box, not shown in Fig. 3.

The robot arm optionally is used in the same way as sensors 1 64, 1 66, 1 68 and
170 in Fig. 1. In addition, the fact that the robot arm can move in a controlled way
under its own power means that it can supplement the NMES, in providing kinesthetic
20 feedback for the patient, if used with the paretic arm. The robot arm provides a
different kind of kinesthetic feedback than NMES provides, since it moves the paretic
arm without causing muscles to contract under their own power, and bom types of
feedback are potentially useful in rehabffitation. For example, NMES may not be able
to produce a smooth and accurate motion by itself, and robot arm can help to correct
25 and smooth the motion induced by NMES.

Optionally, bom the passive and active modes of the robot arm are combined •
with the NMES. Movement generated by the robot arm is assisted by contraction of
' the muscles by NMES. When the patient moves the robot arm in an active way, the
NMES signals are adjusted correspondingly.

Fig. 4 shows an arrangement according to another exemplary embodiment of
the invention, in which only a paretic aim 146 is used. As in Fig. 1, there are EMG
electrodes 148, 150, 152 and 154, attached respectively to the biceps, triceps, flexors
and extensors of the paretic arm, three electrodes for each muscle, and the EMG
signals are conveyed along cables 156, 158, 160, and 162, to an EMG device 120,

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which, after preliminary processing, transmits the signals to controller 124. As in Fig.
1, controller 124 uses the EMG signals in determining the amplitude and timing of
NMES signals transmitted by NMES device 126, which stimulate the biceps, triceps,
flexors and extensors of paretic arm 146 through NMES electrodes 138, 140, 142, and
5 144.

The NMES signals transmitted by NMES device 126 in Fig* 4 are not strong
enough, in themselves, to cause paretic arm 146 to move significantly, and this is
optionally also true in Fig. 1, But the NMES signals, together with the patient's own
nerve impulses, are strong enough to cause the arm to move. Thus, the paretic arm

10 only moves when the patient tries to move it, and the kinesthetic feedback provided
by the motion further encourages the development of alternate pathways for nerve
impulses in the patient, or alternate locations in the motor cortex to originate nerve
impulses to the same muscles, eventually enabling the patient to move the paretic arm
by himself. This may be particularly useful when the motion involves a coordinated

15 sequence of contractions of more than one muscle. Optionally, in the course of
rehabilitation, the NMES signal is lowered, as less NMES signal is needed in order to
allow the patient to move the paretic aim.

Optionally, in the absence of nerve impulses from the patient's motor cortex,
the NMES signals are between 100% and 120% of the amplitude needed to produce

20 motion for an average heajthy subject, or for an average paretic patient, or they are
adjusted to that level for a particular patient. Alternatively, they are between 120%
and 140% of that amplitude for any of these people, or between 80% and 100%, or
between 60% and 80%, or less than 60%, Optionally, for any of these people, the
NMES signals are between 100% and 120% of the level needed to produce motion in

25 the presence of nerve impulses from the motor cortex when the person makes an
effort to move, or between 120% and 140%, or between 140% and 200%, or greater
than 200%.

Optionally, the NMES is targeted to a part of the muscle with at least as much
spatial precision as an average healthy subject is able to achieve when voluntarily
30 directing nerve impulses to that muscle. Alternatively, the NMES is targeted with less
than this much precision, but with at least half this much precision, or with Jess than
half this much precision, but at least one quarter this much precision, or with less than
one quarter this much precision.

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Characteristics of the procedure illustrated in Figs. 1 and 4 can be varied to
adapt to the needs of the patient, in order to facilitate rehabilitation. Several examples

*

are given below.

The EMG and NMES need not use the four muscles shown being used in Figs,

5 1 and 4, but could include more muscles, or fewer muscles. Optionally, only the
biceps and triceps are used initially. Then, once the patient has gained some ability to
use the biceps and triceps effectively;, the flexors and extensors are added to the EMG
and NMES channels. These four muscles are basic to gross control of the arm. Later,
individual fingers are added, and/or other wrist and hand motions, to improve fine

10 motor control. For rehabilitation of body parts other than the arm, of course, other
groups of muscles are selected.

The amplitude of NMES optionally varies depending on feedback from
various sources, and depending on the immediate goal of the rehabilitation program.
As mentioned previously, the NMES signal is optionally decreased as the patient

15 recovers the ability to generate nerve impulses and move his muscles by himself.
Altematively 3 if the immediate goal is the strengthening of atrophied muscles, the
amplitude of NMES is optionally increased as the muscle gets stronger, and can
benefit from more strenuous exercise. In this case, the arm is optionally made to move
against a restraining force; for example a weight or a robotic arm, which is increased

20 as the muscle gets stronger, so a stronger NMES signal is required in order to move
the arm by the same amount

In addition to using kinesthetic feedback to encourage the development of
alternative pathways for nerve impulses, as discussed above, other kinds of feedback
are optionally used to help the patient learn how to control his muscles more

25 effectively. For example, seeing the movement of the arm, when his nerve impulses
are supplemented by NMES stimulation, can help the patient adjust his efforts to
move his arm. Similarly, such feedback for conscious learning by the patient can be
provided by a device, such as the robot arm in Fig. 3, which measures and records the
motion of the arm, and by the processed EMG signals. For example, the patient can

30 try to make the EMG signals from the paretic arm more closely resemble the EMG
signals generated by the healthy arm when it is performing the desired movement, or
he can try to make the EMG signals from the paretic arm more closely resemble some
template, perhaps developed from examining recorded EMG signals from the healthy
arm, or from paretic arms of other patients who have undergone similar rehabilitation.

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In the arrangement shown in Fig, 1, if the patient's other arm is used as the
healthy arm, then optionally the patient tries to move both arms synchronously, in
mirror image movements. The NMES signals, optionally based on the BMG signals of
the healthy arm, allow the paretic arm to move, and since the patient is attempting to
5 move both aims in synchrony, he receives kinesthetic feedback from the paretic aim,
which helps promote the development of alternate pathways for nerve impulses.

Optionally, the NMES signals are adapted to the capability of the paretic arm.
For example, if the muscles in the paretic arm are incapable of responding as rapidly
as normal to the NMES, then the NMES signals are optionally slowed down, or high

■

10 frequency components are reduced or removed. As the muscles recover the capability
of more rapid response, the NMES signals are sped up again. The speed of the NMES
signals is either adjusted automatically, in response to sensor data on movement of the
paretic arm, or manually by the therapist, optionally using such sensor data to evaluate

»

the patient If a robotic arm is used in coordination with NMES to help move the
15 paretic arm, the motion of the robotic arm is optionally slowed down together with the
NMES. Even if the robotic arm is used to help move the paretic arm without NMES,
the motion of the robotic aim is optionally slowed down if, for example, this will help
the patient to make a greater contribution to the motion with his own nerve impulses,
or will be useful for some other reason in rehabilitation.
20 Figs. 5A through 5G illustrate a procedure for rehabilitating a patient who has

a problem that is common following a stroke in the somatomotor cortex— the failure
of the patient's nerve impulses to distinguish adequately between two muscles that

w

form an antagonistic pair, such as the biceps and triceps, or the flexors and extensors.
As shown in Fig. 5A, the EMG signal 402 from the flexors, and signal 404 from the

r

25 extensors, when the patient attempts to open and close her hand, are strong enough to
cause both muscles to contract, since they are above threshold level 406. But both
muscles contract at the same time, so that they work against each other, and the hand
exhibits very little movement First, the patient learns to decrease the overall activity
of both the flexors and extensors, below the threshold for contraction, as shown

30 progressively in Figs. SB, 5C, and 5D. Then, as shown in Figs, 5E, 5F, and 5G, the
patient is taught to increase the activity of the extensors, while keeping the flexors
relaxed. This is done, for example, by applying NMES to the extensors, increasing
kinesthetic feedback, when patient tries to contract the extensors.

10

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To summarize, we list below some of the rehabilitation methods that can be
used, including those discussed.

I ) Record EMG in healthy arm and apply similar pattern of NMES to paretic arm, in
real time or not

5 2) Adjust NMES amplitude to supplement nerve impulses in paretic arm, as measured
by EMG in paretic ana

3) Target NMES to sections of paretic arm where EMG is weak.

4) Slow down NMES to adapt to slow response time of paretic arm.

5) Have patient move both aims together, in mirror image, while applying NMES
10 based on EMG in healthy arm.

6) Have patient move both arms together not in a minor image, and/or in a cyclical
motion 1 80 degrees out of phase, while applying NMES based on (but modified from)
EMG in healthy arm.

7) Base NMES on average EMG over many repetitions of movement by healthy arm.
15 8) Sense position of paretic arm and use negative feedback for NMES; optionally use

EMG of paretic arm to distinguish inability to move arm from intentional resting.
9) Record sensed position of healthy arm as a function of time while recording EMG
signals, (hen apply corresponding NMES to paretic arm when paretic arm is in a
corresponding position.
20 10) Use robotic arm to move healthy arm in a desired pattern, detect the resulting
EMG signals generated passively in the healthy aim, and use them as a basis for
NMES applied to paretic arm to produce corresponding motion.

I I) Use robotic arm and/or. NMES to move or assist moving paretic arm, matching to
measured position of healthy arm.

25 12) Use robot arm to measure resistance of paretic arm to motion, thereby
detennining whether failure of paretic arm to move is due to failure of muscle to
contract, or failure to differentiate between antagonistic pairs of muscles; optionally
adjust NMES accordingly.

13) Use robotic arm, with or without NMES, to assist moving paretic arm, slowing
30 down robotic arm to match capability of paretic arm.

14) Use robotic arm to work against muscles of paretic arm, with or without NMES,
optionally adapting force to capability of paretic arm.

15) Use EMG of paretic arm to teach patient to better control paretic arm, optionally
including better differentiating between antagonistic pairs of muscles.

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As used herein, a "position" of an arm or another body part may include not
just the spatial location of a particular portion of the arm or body part, but any other
information needed to specify its spatial state, including, for example, how much it is
bent at the elbow, how much the forearm is twisted, how much the wrist is bent, etc.
5 The invention has been described in the context of the best mode for carrying

it out It should be understood that not all features shown in the drawing or described
in the associated text may be present in an actual device, in accordance with some
embodiments of the invention. Furthermore, variations on the method and apparatus
shown are included within the scope of the invention, which is limited only by the
10 claims. Also, features of one embodiment may be provided in conjunction with
features of a different embodiment of the invention. As used herein, the terms "have",
■^include" and "comprise" or their conjugates mean ''including but not limited to."

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CLAIMS

1. Apparatus for rehabilitating a patient who has a paretic body part, the
apparatus comprising:

5 a) at least one electromyography (EMG) sensor adapted to being applied to a

voluntary muscle of a healthy body part of the same type as the paretic body
part, which at least one sensor produces at least one EMG signal;
b) a neuromuscular electrical stimulation (NMES) device adapted to stimulating
at least one voluntary muscle of the paretic body part; and

10 c) a controller which controls the NMES device, making the amplitude of

stimulation of the paretic body part at least partly dependent on the EMG
signal from the healthy body part.

2. Apparatus according to claim 1, wherein the at least one muscles of the
IS healthy body part correspond to the at least one muscles of the paretic body part.

3. Apparatus according to claim 2, wherein the controller is configured so that
the NMES stimulates the paretic body part to make a movement corresponding to a
movement made by the healthy body part when the EMG signals are sensed.

20

4. Apparatus according to claim 3, wherein the controller is configured so that
the amplitude of stimulation of at least one of the at least one muscles of the paretic
body part increases when the EMG signal from the corresponding muscle of the
healthy body part increases at a corresponding time in the movement of the healthy

25 body part.

>

5. Apparatus according to claim 3 or claim 4, wherein the at least one muscles of
the paretic body part comprise an antagonistic pair of muscles, and the controller is
configured so that the amplitude of stimulation of one muscle of the antagonistic pair

30 of muscles decreases when the EMG signal from the muscle in the healthy body part
corresponding to the other muscle of the antagonistic pair of muscles increases at a
corresponding time in the movement of the healthy body part.

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6. Apparatus according to any of the preceding claims, wherein one or both of
the controller and the NMES device are configured so that the stimulation amplitude
is not high enough to cause the stimulated muscle to contract in the absence of nerve
impulses from the patient's brain, but is high enough to cause the muscle to contract

5 in the presence of nerve impulses from the patient's brain, for at least some patients
who cannot move said body part by themselves.

7. Apparatus according to any of the preceding claims, wherein the at least one
EMG sensor comprises a plurality of EMG sensors, each EMG sensor adapted to

10 being applied to a different muscle or muscle part of the healthy body pan.

8. Apparatus according to claim 7, wherein each EMG sensor produces a
separate EMG signal.

15 9. Apparatus according to claim 8, wherein the NMES device is adapted to
independently stimulating a plurality of muscles or muscle parts of the paretic body
part

10. Apparatus according to claim 9, wherein said plurality of muscles or muscle
20 parts of the paretic body part correspond to the muscles or muscle parts of the healthy

♦

body part to which the plurality of EMG sensors are adapted to being applied.

♦

11. Apparatus according to claim 10, wherein the controller is configured so that
amplitude of NMES stimulation of said plurality of muscles or muscle parts of the

25 paretic body part is at least partly dependent on the EMG signals from the plurality of
EMG sensors.

12. Apparatus according to claim 11, wherein the controller is configured so that
the amplitude of NMES stimulation of each of said plurality of muscles or muscle

30 parts depends at least partly on the EMG signal from the corresponding muscle or

muscle part.

13. Apparatus according to any of the preceding claims, wherein the paretic body
part is a body part that comes in pairs.

14

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1 4. Apparatus according to claim 1 3, wherein the paretic body part is an arm.

15. Apparatus according to claim 13, wherein the paretic body part is a leg.

5

16. Apparatus according to any of claims 13-15, wherein the healthy body part
belongs to the patient.

17. Apparatus according to any of claims 13-15, wherein the healthy body part
1 0 does not belong to the patient

1 8. Apparatus according to any of the preceding claims, wherein the controller
makes the stimulation amplitude at least partly dependent on a processed form of the
EMG signal.

♦

15

19. Apparatus according to claim 18, wherein the processed form of the EMG
signal is stretched out in time from the EMG signal

20. Apparatus according to. claim 18 or claim 19, wherein the processed form of
20 the EMG signal corresponds to an EMG signal that would be produced by a

movement of the healthy body part that is a mirror image of a movement that the
healthy part was undergoing when the EMG signal was generated.

21. Apparatus according to any of claims 18-20, wherein the processed form of
25 the EMG signal is time delayed from the EMG signal.

. 22. Apparatus according to any of the preceding claims, also including a first
position sensing device which monitors a position of the healthy body part.

30 23. Apparatus according to claim 22, alsoineluding a first actuating device which
mechanically changes the position of the healthy body part.

24. Apparatus according to any of the preceding claims, also including a second
position sensing device which monitors a position of the paretic body part.

15

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*

25. Apparatus according to claim 24, also including a second actuating device
-which mechanically changes the position of the paretic body part

S 26* Apparatus adapted for rehabilitating a class of patients who have a paretic
body part, the apparatus comprising a neuromuscular electrical stimulation (NMES)

4

device adapted to stimulating at least one voluntary muscle in the paretic body,
wherein the amplitude of stimulation is not sufficient by itself to cause contraction of
said muscle, but the amplitude of stimulation is sufficient to cause contraction of said

■

1 0 muscle when a patient in said class attempts to move the body part at the same time.

27. Apparatus according to any of the preceding claims, also including at least one
paretic EMG sensor adapted for applying to a voluntary muscle of the. paretic body
part, which at least one paretic EMG sensor produces at least one paretic EMG signal.

15

28. Apparatus according to claim 27, wherein the controller makes the amplitude
of stimulation of the paretic body part at least partly dependent on the at least one

* *

paretic EMG signal

20 29. Apparatus accoiding to claim 28, wherein the at least one paretic EMG sensors
adapted for applying to the paretic body part comprise a plurality of paretic EMG
sensors, each adapted for applying to a different muscle or muscle part of the paretic
body pari, and each producing a separate paretic EMG signal.

25 30. Apparatus according to claim 29, wherein the NMES device is adapted to
stimulate the muscles or muscle parts of the paretic body that the paretic EMG sensors
arc adapted for being applied to, and the controller is configured to make the
amplitude of stimulation of each muscle or muscle part depend at least partly on the
paretic EMG signal from that muscle or muscle part

30

31. A method of rehabilitating a patient who has a paretic body part, the method
comprising:

a) having the patient or another person move a healthy body part that is of the
same type as the paretic body part;

«

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b) detecting EMG signals from the healthy body part while it is being moved;
and

c) applying NMES to the paretic body part, at an amplitude that depends at least
partly on the EMG signals.

5

32. A method according to claim 31, also including having die patient attempt to
move the paretic body part, while the NMES is applied, in the same pattern of
movement that the healthy body part is moved in while the EMG signals are detected.

10 33. A method according to claim 32, wherein detecting the EMG signals
. comprises detecting the EMG signals from a plurality of muscles or muscle parts of
the healthy body part, and applying NMES comprises applying NMES to a plurality
of muscles or muscle parts of the paretic body part corresponding to the plurality of
muscles or muscle parts of the healthy body part

34. A method according to claim 33, wherein the amplitude of NMES applied to
each muscle or muscle part of the paretic body part during a time interval in the
pattern of attempted movement of the paretic body part depends at least partly on the
EMG signal detected from the corresponding muscle or muscle part of the healthy
20 body, during a corresponding time interval in the pattern of movement of the healthy
body part

17

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abstract;

Apparatus for rehabilitating a patient who has a paretic body part, the apparatus
comprising:

a) at least one electromyography (EMG) sensor adapted to being applied to a
5 voluntary muscle of a healthy body part of the same type as the paretic body

part, which at least one sensor produces at least one EMG signal;

b) a neuromuscular electrical stimulation (NMES) device adapted to stimulating
at least one voluntary muscle of the paretic body part; and

»

c) a controller which controls the NMES device, making the amplitude of
10 stimulation of the paretic body part at least partly dependent on the EMG

signal from the healthy body part.

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404

FIG.5A

404

SEC i

FIG.5B

SEC

FIG.5C

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SEC r
0

^€4 406 402

uV
-20

-10

7 14

FIG.5D

21

SECr
0

7 14

FIG.5E

FIG.5F

FIG.5G